combination of dextromethorphan and memantine in treating bipolar disorder

Conditions: Bipolar Disorder II

Summary: this is a research clinical trial of double-blind, stratified randomized, parallel group, two-centre study. it will be conducted in a total of 250\~300 male and female subjects from the department of psychiatry at national cheng kung university hospital. eligible subjects will be psychiatric out- and in-patients, aged between 18\~65 years old, who have psychiatric evaluation with clinically suspected of having bipolar ii disorder and fulfill the inclusion and exclusion criteria. the add-on double-blind study treatment with dextromethorphan/place will commence at randomization for while patients continue open-label valproate. subjects will be enrolled for 12 weeks double-blind add-on treatment and randomly assigned to (1) 30mg dextromethorphan+valproate, (2) 5mg memantine+valproate, (3) dextromethorphan+memantine+valproate or (4) placebo+valproate. concomitant benzodiazepine medication (preferably up to 8mg lorazepam) may be used for daytime sedation, agitation or insomnia during the study. for the consideration of the less influence to immune-system, resperidone 1-3mg/daily and fluoxetine maximum 20mg/daily will be chose. we will measure the treatment response and side effect to clarify the curative effect of dm and memantine add-on therapy to valproate in the treatment of bipolar disorders. this study is being performed to investigate the possibly significant beneficial effects on the subtypes of bipolar disorders psychopathology.

a total of 250\~300 male and female subjects from the department of psychiatry at national cheng kung university hospital. eligible subjects who are aged between 18\~65 years old and clinically suspected of having bipolar ii disorder are invited. the add-on double-blind study treatment with dextromethorphan/place will commence at randomization for while patients continue open-label valproate. subjects will be enrolled for 12 weeks double-blind add-on treatment and randomly assigned to (1) 30mg dextromethorphan+valproate, (2) 5mg memantine+valproate, (3) dextromethorphan+memantine+valproate or (4) placebo+valproate. concomitant benzodiazepine medication (preferably up to 8mg lorazepam) may be used for daytime sedation, agitation or insomnia during the study. for the consideration of the less influence to immune-system, resperidone 1-3mg/daily and fluoxetine maximum 20mg/daily will be chose. we will measure the treatment response and side effect to clarify the curative effect of dm and memantine add-on therapy to valproate in the treatment of bipolar disorders. this study is being performed to investigate the possibly significant beneficial effects on the subtypes of bipolar disorders psychopathology.

Eligibility criteria:
inclusion criteria: * a 2-day minimum for hypomania to diagnose bipolar ii disorder * a total of hamilton rating scale for depression scored at least 18 or young mania rating scale scored at least 14 at the screening stage * must allow to ensure acceptable compliance and visit exclusion criteria: * pregnant females or nursing * women of childbearing potential not using adequate contraception * received dextromethorphan, memantine, other antiinflammatory medication within 1 week prior * clinically significant medical condition (cardiac, hepatic and renal disease) * received electroconvulsive therapy patients within 4 weeks prior to the first dose of double-blind medication * increase in total sgot, sgpt, bun and creatinine by more than 3x upper limit of normal.

Keywords: dextromethorphan; memantine; treatment response